According to research published early online in the Journal of Clinical Oncology, the addition of cetuximab to the combination of a taxane with carboplatin (TC) does not improve the primary end point, progression-free survival (PFS-IRRC) in NSCLC patients.

Researchers evaluated the efficacy of cetuximab in combination with taxane/carboplatin (TC) vs. TC as first-line treatment of advanced non–small-cell lung cancer (NSCLC) in the BMS099 trial. The phase III study involved 676 chemotherapy-naïve patients with stage IIIB (pleural effusion) or IV NSCLC who were randomised to receive cetuximab in combination with a taxane and carboplatin, or a taxane and carboplatin only. TC consisted of paclitaxel (225 mg/m2) or docetaxel (75 mg/m2), at the investigator's discretion, and carboplatin (area under the curve = 6) on day 1 every 3 weeks for </= 6 cycles; cetuximab (400 mg/m2 on day 1, 250 mg/m2 weekly) was administered until progression or unacceptable toxicity. The primary end point was progression-free survival as assessed by an independent radiologic review committee (PFS-IRRC). Secondary end points were overall response rate (ORR), overall survival (OS), quality of life (QoL), and safety.

The following results were reported:
• Median PFS-IRRC was 4.40 months with cetuximab/TC versus 4.24 months with TC (hazard ratio [HR] = 0.902; 95% CI, 0.761 to 1.069; P = 0.236).
• Median OS was 9.69 months with cetuximab/TC versus 8.38 months with TC (HR = 0.890; 0.754 to 1.051; P = 0.169).
• ORR-IRRC was 25.7% with cetuximab/TC versus 17.2% with TC (P = 0.007).

The researchers highlighted that this trial was designed as a supportive trial to the phase III FLEX trial. Although it did not meet its primary end point, there are some similarities with the FLEX trial. Both studies showed a statistically significant benefit in ORR with the addition of cetuximab to chemotherapy. Both studies failed to show any improvement in PFS. However, the difference in OS was similar in both studies (approximately 1.3-month increase in median OS and 11% to 13% reduction in the death risk), although BMS099 lacked power to detect a difference of this magnitude with statistical significance.

[Editor’s note: The open-label, phase III FLEX (First Line ErbituX in lung cancer) trial compared chemotherapy plus cetuximab with chemotherapy alone in patients with advanced EGFR-positive non-small-cell lung cancer (NSCLC) – please see link below for NeLM report of this study]